CompletedPhase 2

Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

United States25 participantsStarted 2021-06-21

Plain-language summary

The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening * History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record. * Body mass index (BMI) of up to 40 kg/m2 * If female, must not be breastfeeding and must have a negative urine pregnancy test result Exclusion Criteria: * Major surgery within 6 months before randomization. * History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia). * Use of agents that may interfere with glucose metabolism

What they're measuring

Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)

Timeframe: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Trial details

NCT IDNCT04652479

SponsorDr. Tracey McLaughlin, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2023-04-10

View on ClinicalTrials.gov More Acquired Hyperinsulinemic Hypoglycemia trials